Quality Control Analyst II

Quality Control Analyst II

Location: Rensselaer, NY Shift: This role is an overnight 12-hour rotating shift position. Our client is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients.

Job Type: Full time Industry: Pharma

Job Description:

The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential job duties:

• Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
• Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling
• Back up for QC analytical instrument maintenance and calibration
• Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
• Perform or assist with QC method qualifications, transfers and validations
• Perform QC method development
• Perform OOS investigations and lab deviation investigations
• Provide technical support for shift analysts
• Perform cleaning validation studies
• Assist with the evaluation of new equipment and processes
• Assist in the review of QC data and provide summaries to management as needed
• Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC
• Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure

Education, experience, certification and licensures:

Required: Bachelor's degree in Chemistry or related field; Minimum 3-5 years' experience in pharmaceutical industry environment or equivalent combination of education and experience

Preferred: Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities:

Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

Ability to meet deadlines and work under pressure with limited supervision

Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Ability to write reports, business correspondence, and procedure manuals

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations

Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis

Ability to define problems, collect data, establish facts, and draw valid conclusions

Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems

Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Physical requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment:

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one's environment and taking proper precautions is required). The noise level in the work environment is usually moderate. Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

Pay Range: $63,000 - $79,000